CN103099825B - Novel cordyceps sinensis capsule and preparation method thereof - Google Patents
Novel cordyceps sinensis capsule and preparation method thereof Download PDFInfo
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- CN103099825B CN103099825B CN201310034277.1A CN201310034277A CN103099825B CN 103099825 B CN103099825 B CN 103099825B CN 201310034277 A CN201310034277 A CN 201310034277A CN 103099825 B CN103099825 B CN 103099825B
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- 239000002775 capsule Substances 0.000 title claims abstract description 36
- 238000002360 preparation method Methods 0.000 title claims abstract description 21
- 241001248610 Ophiocordyceps sinensis Species 0.000 title abstract description 9
- 239000008187 granular material Substances 0.000 claims abstract description 92
- 239000000843 powder Substances 0.000 claims abstract description 60
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 31
- 229930195725 Mannitol Natural products 0.000 claims abstract description 29
- 239000000594 mannitol Substances 0.000 claims abstract description 29
- 235000010355 mannitol Nutrition 0.000 claims abstract description 29
- 239000011230 binding agent Substances 0.000 claims abstract description 20
- 239000000945 filler Substances 0.000 claims abstract description 15
- 239000000203 mixture Substances 0.000 claims abstract description 8
- 241000190633 Cordyceps Species 0.000 claims description 85
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical group CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 27
- 229920002472 Starch Polymers 0.000 claims description 16
- 239000008107 starch Substances 0.000 claims description 16
- 235000019698 starch Nutrition 0.000 claims description 16
- 241000233866 Fungi Species 0.000 claims description 15
- 240000001307 Myosotis scorpioides Species 0.000 claims description 15
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 9
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 9
- 230000008602 contraction Effects 0.000 claims description 9
- 239000011734 sodium Substances 0.000 claims description 9
- 229910052708 sodium Inorganic materials 0.000 claims description 9
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 8
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 8
- 238000005469 granulation Methods 0.000 claims description 7
- 230000003179 granulation Effects 0.000 claims description 7
- 238000011049 filling Methods 0.000 claims description 6
- 239000007779 soft material Substances 0.000 claims description 6
- 229920001353 Dextrin Polymers 0.000 claims description 5
- 239000004375 Dextrin Substances 0.000 claims description 5
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 5
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 5
- 235000019425 dextrin Nutrition 0.000 claims description 5
- 239000008101 lactose Substances 0.000 claims description 5
- 239000000741 silica gel Substances 0.000 claims description 5
- 229910002027 silica gel Inorganic materials 0.000 claims description 5
- 235000019359 magnesium stearate Nutrition 0.000 claims description 4
- 238000009818 secondary granulation Methods 0.000 claims description 3
- 238000010521 absorption reaction Methods 0.000 abstract description 9
- 230000000694 effects Effects 0.000 abstract description 7
- 238000000034 method Methods 0.000 abstract description 7
- 239000004615 ingredient Substances 0.000 abstract description 6
- 238000000855 fermentation Methods 0.000 abstract description 3
- 230000004151 fermentation Effects 0.000 abstract description 3
- 238000005453 pelletization Methods 0.000 abstract 4
- 239000003795 chemical substances by application Substances 0.000 abstract 2
- 239000011248 coating agent Substances 0.000 abstract 1
- 238000000576 coating method Methods 0.000 abstract 1
- 230000004526 pharmaceutical effect Effects 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 4
- 239000007902 hard capsule Substances 0.000 description 4
- 239000002994 raw material Substances 0.000 description 4
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- 238000004519 manufacturing process Methods 0.000 description 2
- 239000007901 soft capsule Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 241000221751 Claviceps purpurea Species 0.000 description 1
- KQLDDLUWUFBQHP-UHFFFAOYSA-N Cordycepin Natural products C1=NC=2C(N)=NC=NC=2N1C1OCC(CO)C1O KQLDDLUWUFBQHP-UHFFFAOYSA-N 0.000 description 1
- AUNGANRZJHBGPY-UHFFFAOYSA-N D-Lyxoflavin Natural products OCC(O)C(O)C(O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-UHFFFAOYSA-N 0.000 description 1
- 241000130660 Hepialidae Species 0.000 description 1
- AUNGANRZJHBGPY-SCRDCRAPSA-N Riboflavin Chemical compound OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-SCRDCRAPSA-N 0.000 description 1
- 240000006698 Spigelia anthelmia Species 0.000 description 1
- 229930003451 Vitamin B1 Natural products 0.000 description 1
- 229930003471 Vitamin B2 Natural products 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 229930013930 alkaloid Natural products 0.000 description 1
- 150000003797 alkaloid derivatives Chemical class 0.000 description 1
- 235000001014 amino acid Nutrition 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
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- 239000000470 constituent Substances 0.000 description 1
- OFEZSBMBBKLLBJ-BAJZRUMYSA-N cordycepin Chemical compound C1=NC=2C(N)=NC=NC=2N1[C@@H]1O[C@H](CO)C[C@H]1O OFEZSBMBBKLLBJ-BAJZRUMYSA-N 0.000 description 1
- OFEZSBMBBKLLBJ-UHFFFAOYSA-N cordycepine Natural products C1=NC=2C(N)=NC=NC=2N1C1OC(CO)CC1O OFEZSBMBBKLLBJ-UHFFFAOYSA-N 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
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- 239000000284 extract Substances 0.000 description 1
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- 239000003925 fat Substances 0.000 description 1
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- 150000004676 glycans Chemical class 0.000 description 1
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- 238000002386 leaching Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
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- 239000012567 medical material Substances 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 235000010755 mineral Nutrition 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 235000018102 proteins Nutrition 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 229960002477 riboflavin Drugs 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- -1 superdisintegrantes Substances 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
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- DPJRMOMPQZCRJU-UHFFFAOYSA-M thiamine hydrochloride Chemical compound Cl.[Cl-].CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N DPJRMOMPQZCRJU-UHFFFAOYSA-M 0.000 description 1
- 230000001256 tonic effect Effects 0.000 description 1
- 235000010374 vitamin B1 Nutrition 0.000 description 1
- 239000011691 vitamin B1 Substances 0.000 description 1
- 235000019164 vitamin B2 Nutrition 0.000 description 1
- 239000011716 vitamin B2 Substances 0.000 description 1
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- Medicines Containing Plant Substances (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention provides a cordyceps sinensis capsule with stronger effect and more stable characters and a preparation method thereof. The cordyceps sinensis capsule provided by the invention comprises granule content and a capsule shell, wherein the granule content comprises a granule kernel and a granule shell, the granule kernel is made by adding a binding agent into a cordyceps sinensis fermentation mycelium, a filler and a high-efficiency disintegrating agent, extruding, contracting and pelletizing; and the granule shell is formed by adding the binding agent into cordyceps sinensis, mannitol and the high-efficiency disintegrating agent and coating mixture at the periphery of the granule kernel by secondary pelletizing. The cordyceps sinensis capsule provided by the invention has the obvious advantages that an original two-step pelletizing method is adopted, firstly the granule kernel containing cordyceps sinensis fermentation mycelium ultrafine powder is prepared, and then natural cordyceps sinensis ultrafine powder and mannitol are coated at the periphery of the granule kernel by adopting secondary pelletizing, so that the granule shell is formed; and natural effective ingredients and mannitol can be dissolved more easily, absorption is promoted, and pharmaceutical effect is played.
Description
Technical field
The invention belongs to medicine or health products production field, relate to capsule of Chinese caterpillar fungus that a kind of effect is stronger, character is more stable and preparation method thereof.
Background technology
Natural cordyceps is that section ergot fungus cordyceps sinensis bacterium colonizes in Stroma and the larva cadaveric complex on Hepialidae insect larvae, is a kind of traditional famous and precious tonic Chinese medicine material; Base in Mycelia of Cordyceps is the kind that people adopt new bio technology liquid fermentation and culture to obtain in recent years, through the Cordyceps mycelium of artificial culture, is easy to obtain, and price is relatively low.The multiple efficacies such as both adjusting function of immune system, antitumor, resisting fatigue, main active has: cordycepic acid, cordycepin, aminoacid, Cordyceps polysaccharide, alkaloid, protein, fat, vitamin B1, B2 and mineral etc.
At present worm grass product on the market mainly contains tablet, pill, soft capsule, hard capsule, but all formula or the technologic problem of various degrees.How to bring into play to greatest extent the effect of natural cordyceps or Base in Mycelia of Cordyceps and how to increase the key that its stability in producing storage and transport process becomes product.
A lot of products adopt extraction process to attempt by the extracts active ingredients in natural cs or mycelium out, make the corresponding dosage forms such as soft capsule, but the effective ingredient in Cordyceps is complicated, different to hot sensitivity, and the dissolubility in identical solvent is also different, so be difficult to find one or both solvents all known or unknown compositions to be extracted, therefore validity of products is had a greatly reduced quality simultaneously.
In addition, some products all adopt natural Cordyceps, and price is very expensive; Some products adopt Base in Mycelia of Cordyceps to do raw material, and price is lower, but cannot reach the efficacy levels equal with natural cordyceps; Also have product that both are mixed and do raw material with definite proportion row, but generally all raw material is simply pulverized with the direct fill capsule of powder or tabletting, with low content of technology, product stability is poor.
Owing to wanting fully to retain the effective ingredient of natural cordyceps or Cordyceps mycelium and bring into play drug effect, effective method is made broken wall treatment by natural cordyceps or Cordyceps mycelium through micronizing exactly now, makes superfine powder.Once but make superfine powder, the mobility of powder body will reduce greatly, so realize batch production if want, enhances productivity, just must be by powder body granulation.In addition, raw material carries out after micronizing processing, and its hygroscopicity significantly promotes.For guaranteeing the stability of product in production and storage process, the moisture absorption that prevents granule is also the key of technique.
Summary of the invention
The object of this invention is to provide capsule of Chinese caterpillar fungus that a kind of novel effect is stronger, character is more stable and preparation method thereof.
Realizing technical solution of the present invention is: a kind of novel capsule of Chinese caterpillar fungus, is made by micronizing, two step granulations, oven dry, granulate, fill capsule by natural cordyceps, Base in Mycelia of Cordyceps, mannitol, filler, superdisintegrantes, binding agent, fluidizer.
A preparation method for novel capsule of Chinese caterpillar fungus, comprises the following steps:
Step 1: natural cordyceps and Base in Mycelia of Cordyceps are made to superfine powder with super micron mill as broken wall treatment respectively;
Step 2: Base in Mycelia of Cordyceps superfine powder is mixed with filler, superdisintegrantes, add binding agent and prepare soft material, then by squeezing contraction grain machine granulation, and the granule making is dried;
Step 3: the granule of step 2 gained is mixed homogeneously with natural cordyceps superfine powder, mannitol, superdisintegrantes, add binding agent and carry out secondary granulation, until the mixture of natural cordyceps superfine powder, mannitol and superdisintegrantes is evenly bonded in the granule periphery of step 2 gained, sieves the granule making is dried;
Step 4: add fluidizer to mix in the granule of step 3 gained and carry out granulate;
Step 5: the granule filling capsule by step 4 gained, makes finished product.
The present invention and existing product ratio, the remarkable advantage in formula and Technology is:
1, natural cordyceps and Base in Mycelia of Cordyceps are carried out to rational proportion, guaranteeing under the prerequisite of effect, by cost compression, Wei Gengduo consumer accepts;
2, in preparation technology, use wall breaking technology, avoided loss and the destruction of effective ingredient in leaching process, fully retained natural cs or mycelial effective ingredient; Micronization can promote drug absorption, accelerates onset time, increases the bioavailability of medicine, and reduces dosage, saves medical material;
3, one of effective ingredient of Cordyceps is cordycepic acid, is mannitol.The mannitol of usining can play to the effect of Cordyceps the effect of gain as the filler of granule;
4, in preparation technology, adopt crowded contraction grain can increase granular pile density, when not changing single oral dose, improve capsule loading amount, thereby reach minimizing capsule, take a number, improve the object of patient's compliance; In addition, it is long-pending that this technology can reduce specific grain surface effectively, increases granule compactness, thereby prevent that absorption from, compared with juicy, reaching moistureproof object;
5, adopt two step granulations of original creation, the granule kernel that first preparation contains Base in Mycelia of Cordyceps superfine powder, then granulate natural cordyceps superfine powder and mannitol are wrapped in to granule kernel periphery by secondary, form granule shell.On the one hand mannitol is distributed in to granule housing parts, utilizes the non-hygroscopic property of mannitol, controlled the moisture absorption of granule integral body; On the other hand natural Cordyceps and mannitol are distributed in to the housing parts of granule, are easier to the stripping of natural constituent and mannitol, promote to absorb, performance drug effect;
6, the present invention is hard capsule, and the content granule of hard capsule is directly to fill, though sometimes must be to content precompressed, general pressure is 20～30N, and the pressure of tablet is generally 3 * 10
4n, so compared with tablet, the stripping property of hard capsule is better, and preparation technology is simple, is applicable to batch production.
Accompanying drawing explanation
Preparation technology's flow chart of the capsule of Chinese caterpillar fungus that Fig. 1 the present invention relates to
Fig. 2 is by the prepared content grain structure of the capsule of Chinese caterpillar fungus preparation technology figure the present invention relates to
The specific embodiment
A kind of novel capsule of Chinese caterpillar fungus, comprise content granule and capsule shells, wherein content granule comprises granule kernel and granule shell two parts, and wherein granule kernel is by Base in Mycelia of Cordyceps, filler, superdisintegrantes, add binding agent, by squeezing contraction grain, make; Granule shell, by natural cordyceps, mannitol, superdisintegrantes, adds binding agent, by secondary, is granulated and is wrapped in granule kernel periphery, forms granule shell.Wherein filler is starch, lactose or dextrin etc.; Superdisintegrantes is carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose etc.; Binding agent is ethanol.
A preparation method for novel capsule of Chinese caterpillar fungus, comprises the following steps:
Step 1: natural cordyceps and Base in Mycelia of Cordyceps are made to superfine powder more than 1000 orders with super micron mill as broken wall treatment respectively; Wherein the mass ratio of Base in Mycelia of Cordyceps superfine powder and natural cordyceps superfine powder is 5:1～20:1;
Step 2: Base in Mycelia of Cordyceps superfine powder is mixed with filler, superdisintegrantes, add binding agent until agglomerating, the i.e. loose soft material that touches that obtains holding by squeezing contraction grain machine granulation, and dried the granule making; Wherein the mass ratio of filler and Base in Mycelia of Cordyceps superfine powder is 1:2～1:8, and the mass ratio of superdisintegrantes and Base in Mycelia of Cordyceps superfine powder is 1:20～1:80; The granule making is 50 orders; Bake out temperature is 60～80 ℃; Wherein filler is starch, lactose or dextrin; Superdisintegrantes is carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose; Binding agent is 30%～80% ethanol;
Step 3: the granule of step 2 gained is mixed homogeneously with natural cordyceps superfine powder, mannitol, superdisintegrantes, add binding agent to carry out secondary granulation, until the mixture of natural cordyceps superfine powder, mannitol and superdisintegrantes is evenly bonded in the granule periphery of step 2 gained, sieves and the granule obtaining is dried; Wherein the mass ratio of mannitol and natural cordyceps superfine powder is 1:1～3:1, and the mass ratio of superdisintegrantes natural cordyceps superfine powder is 1:5～1:10; Crossing grit number is 20 orders; Bake out temperature is 60～80 ℃; Wherein superdisintegrantes is carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose; Binding agent is 30%～80% ethanol;
Step 4: add fluidizer to mix in the granule of step 3 gained and granulate; The quality that wherein adds fluidizer be in step 3 gained granule total amount 0.1%～1%; Wherein fluidizer is magnesium stearate or micropowder silica gel;
Step 5: the granule filling capsule by step 4 gained, makes finished product.
Below in conjunction with specific embodiment, the present invention is described in detail.
The preparation method of 1 one kinds of capsules of Chinese caterpillar fungus of embodiment, comprises the following steps:
Step 1: natural cordyceps and Base in Mycelia of Cordyceps are made to superfine powder more than 1000 orders with super micron mill as broken wall treatment respectively;
Step 2: get 5kg Base in Mycelia of Cordyceps superfine powder and starch 2.5kg, carboxymethyl starch sodium 0.25kg, add 80% ethanol until agglomerating, the i.e. loose soft material that touches that obtains holding, by squeezing contraction grain machine, make 50 object granules, and the granule making is carried out to 60 ℃ of oven dry;
Step 3: the granule of step 2 gained is mixed homogeneously with 1kg natural cordyceps superfine powder, mannitol 1kg, carboxymethyl starch sodium 0.2kg, add 80% ethanol until the mixture of natural cordyceps superfine powder, mannitol and superdisintegrantes is evenly bonded in the granule periphery of step 2 gained, cross 20 object screen clothes and the granule of gained is carried out to 60 ℃ of oven dry;
Step 4: add magnesium stearate 0.01kg to mix in the granule of step 3 gained and carry out granulate;
Step 5: the granule filling capsule by gained in step 4, makes finished product.
The preparation method of 2 one kinds of capsules of Chinese caterpillar fungus of embodiment, comprises the following steps:
Step 1: natural cordyceps and Base in Mycelia of Cordyceps are made to superfine powder more than 1000 orders with super micron mill as broken wall treatment respectively;
Step 2: get the 0.16kg such as 8kg Base in Mycelia of Cordyceps superfine powder and lactose 1.6kg, low-substituted hydroxypropyl cellulose, add 60% ethanol until agglomerating, the i.e. loose soft material that touches that obtains holding, by squeezing contraction grain machine, make 50 object granules, and the granule making is carried out to 70 ℃ of oven dry;
Step 3: the granule of step 2 gained is mixed homogeneously with 0.1kg such as 0.8kg natural cordyceps superfine powder, mannitol 1.6kg, low-substituted hydroxypropyl celluloses, add 60% ethanol until the mixture of natural cordyceps superfine powder, mannitol and superdisintegrantes is evenly bonded in the granule periphery of step 2 gained, cross 20 object screen clothes and the granule of gained is carried out to 70 ℃ of oven dry;
Step 4: add micropowder silica gel 0.06kg to mix in the granule of step 3 gained and carry out granulate;
Step 5: the granule filling capsule by step 4 gained, makes finished product.
The preparation method of 3 one kinds of capsules of Chinese caterpillar fungus of embodiment, comprises the following steps:
Step 1: natural cordyceps and Base in Mycelia of Cordyceps are made to superfine powder more than 1000 orders with super micron mill as broken wall treatment respectively;
Step 2: get 10kg Base in Mycelia of Cordyceps superfine powder and dextrin 1.25kg, low-substituted hydroxypropyl cellulose 0.25kg, add 30% ethanol until agglomerating, the i.e. loose soft material that touches that obtains holding, by squeezing contraction grain machine, make 50 object granules, and the granule making is carried out to 80 ℃ of oven dry;
Step 3: the granule of step 2 gained is mixed homogeneously with 0.05kg such as 0.5kg natural cordyceps superfine powder, mannitol 1.5kg, low-substituted hydroxypropyl celluloses, add 30% ethanol until the mixture of natural cordyceps superfine powder, mannitol and superdisintegrantes is evenly bonded in the granule periphery of step 2 gained, cross 20 object screen clothes and the granule making is carried out to 80 ℃ of oven dry;
Step 4: add micropowder silica gel 0.14kg to mix in the granule of step 3 gained and carry out and granulate;
Step 5: by step 4 gained granule filling capsule, make finished product.
As shown in Figure 2, wherein 1 is granule shell to the structure of the prepared capsule of Chinese caterpillar fungus content of the present invention granule, comprises natural cordyceps superfine powder and mannitol, and 2 is granule kernel, comprises Base in Mycelia of Cordyceps superfine powder.
By disintegration and capsule 's content, the moisture absorption weightening finish under super-humid conditions compares the sample that three kinds of embodiment are made with the another matched group 1 of preparing, matched group 2, measures and all according to correlation technique in 2010 editions > > of < < Chinese Pharmacopoeia, operates.
Matched group 1 is ground into respectively superfine powder more than 1000 orders by natural cordyceps 30g and Base in Mycelia of Cordyceps 300g, mixes with starch 100g, magnesium stearate 8g, records capsule and makes 1000; Matched group 2 is ground into respectively superfine powder more than 1000 orders by natural cordyceps 30g and Base in Mycelia of Cordyceps 300g, and with starch 100g, carboxymethyl starch sodium 10g mixes, add 50% alcohol granulation, 80 ℃ of oven dry, add after micropowder silica gel 4g mixing, and fill capsule makes 1000.
Moisture absorption under the disintegration of five groups of samples and capsule 's content super-humid conditions weightening finish comparative result is as following table:
| ? | Matched group 1 | Matched group 2 | Embodiment 1 | Embodiment 2 | Embodiment 3 |
| Disintegration (on average) | 10.4min | 12.7min | 11.1min | 11.7min | 11.3min |
| Moisture absorption weightening finish (on average) | 9.3% | 8.5% | 2.6% | 2.8% | 3.0% |
By upper table, seen, all meet disintegrate requirement completely in 30 minutes in pharmacopeia the disintegration of embodiment, and moisture absorption weightening finish is all starkly lower than matched group 1 and matched group 2, good stability under super-humid conditions.
Claims (6)
1. a novel capsule of Chinese caterpillar fungus, comprise content granule and capsule shells, it is characterized in that, content granule comprises granule kernel and granule shell two parts, wherein granule kernel is mixed by Base in Mycelia of Cordyceps superfine powder, filler, superdisintegrantes, add binding agent, by squeezing contraction grain, make; Granule shell, by natural cordyceps superfine powder, mannitol, superdisintegrantes, adds binding agent, by secondary, is granulated and is wrapped in granule kernel periphery, forms granule shell; Wherein natural cordyceps superfine powder and Base in Mycelia of Cordyceps superfine powder carry out broken wall treatment by super micron mill to natural cordyceps and Base in Mycelia of Cordyceps and make;
Described filler is starch, lactose or dextrin; Superdisintegrantes is carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose; Binding agent is ethanol; The mass ratio of described Base in Mycelia of Cordyceps superfine powder and natural cordyceps superfine powder is 5:1 ~ 20:1; In granule kernel, the mass ratio of filler and Base in Mycelia of Cordyceps superfine powder is 1:2 ~ 1:8, and the mass ratio of superdisintegrantes and Base in Mycelia of Cordyceps superfine powder is 1:20 ~ 1:80; In granule shell, the mass ratio of mannitol and natural cordyceps superfine powder is 1:1 ~ 3:1, and the mass ratio of superdisintegrantes and natural cordyceps superfine powder is 1:5 ~ 1:10; Described binding agent is 30% ~ 80% ethanol.
2. the preparation method of novel capsule of Chinese caterpillar fungus as claimed in claim 1, is characterized in that, comprises the following steps:
Step 1: natural cordyceps and Base in Mycelia of Cordyceps are made to superfine powder with super micron mill as broken wall treatment respectively;
Step 2: Base in Mycelia of Cordyceps superfine powder is mixed with filler, superdisintegrantes, add binding agent until agglomerating, the i.e. loose soft material that touches that obtains holding by squeezing contraction grain machine granulation, and dried the granule making;
Step 3: the granule of step 2 gained is mixed homogeneously with natural cordyceps superfine powder, mannitol, superdisintegrantes, add binding agent to carry out secondary granulation, until the mixture of natural cordyceps superfine powder, mannitol and superdisintegrantes is evenly bonded in the granule periphery of step 2 gained, sieves and the granule of gained is dried;
Step 4: add fluidizer to mix in the granule of step 3 gained and granulate;
Step 5: the granule filling capsule by step 4 gained, makes finished product.
3. according to the preparation method described in claim 2, it is characterized in that, the superfine powder of making in step 1 is more than 1000 orders; Wherein the mass ratio of Base in Mycelia of Cordyceps superfine powder and natural cordyceps superfine powder is 5:1 ~ 20:1.
4. according to the preparation method described in claim 2, it is characterized in that, in step 2, the mass ratio of filler and Base in Mycelia of Cordyceps superfine powder is 1:2 ~ 1:8, and the mass ratio of superdisintegrantes and Base in Mycelia of Cordyceps superfine powder is 1:20 ~ 1:80; The granule making is 50 orders; Bake out temperature is 60 ~ 80 ℃; Wherein filler is starch, lactose or dextrin; Superdisintegrantes is carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose; Binding agent is 30% ~ 80% ethanol.
5. according to the preparation method described in claim 2, it is characterized in that, in step 3, the mass ratio of mannitol and natural cordyceps superfine powder is 1:1 ~ 3:1, and the mass ratio of superdisintegrantes natural cordyceps superfine powder is 1:5 ~ 1:10; Crossing grit number is 20 orders; Bake out temperature is 60 ~ 80 ℃; Wherein superdisintegrantes is carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose; Binding agent is 30% ~ 80% ethanol.
6. according to the preparation method described in claim 2, it is characterized in that, the quality that adds fluidizer be in step 3 gained granule total amount 0.1% ~ 1%; Wherein fluidizer is magnesium stearate or micropowder silica gel.
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